Intrauterine contraceptive devices with plural parallel leg segments

ABSTRACT

An intrauterine contraceptive device comprising an elongated shank having divergent convoluted portions at its distal end, the convoluted portions being generally sinusoidal in nature, the device having incorporated in the shank a permanent magnet and having a substantial portion of its surface covered with a biologically inert, silicone elastomeric material which may contain an analgaesic or anti-fertility agent which is gradually released in utero. In a preferred embodiment of the invention, the proximal end of the shank contains a pair of downwardly extending divergent, resilient legs which tend to prevent inadvertent expulsion of the device. In another preferred embodiment, the lower end of the device is formed with a small container for certain types of medication which are released gradually into the vagina over a prolonged period of time for the prevention and cure of such diseases as gonorrhea and syphilis.

United States Patent 1 Gutnick 1 Oct. 21, 1975 [76] Inventor: MortonGutnick, 8329 Fairview Road, Elkins Park, Pa. 19117 [22] Filed: Jan. 11,1974 [21] Appl. No; 432,435

Related [1.8. Application Data [63] Continuation-impart of Ser. No.294,200, Oct. 2,

1972, abandoned.

Vennard 128/129 Ansan 128/130 Primary Examiner-Richard A. GaudetAssistant Examiner.1. C. McGowan Attorney, Agent, or FirmRobert S.Bramson, Esqx, James A. Drobile, Esq.

[57] ABSTRACT An intrauterine contraceptive device comprising anelongated shank having divergent convoluted portions at its distal end,the convoluted portions being generally sinusoidal in nature, the devicehaving incorporated in the shank a permanent magnet and having asubstantial portion of its surface covered with a biologically inert,silicone elastomeric material which may contain an analgaesic orantifertility agent which is gradually released in utero. in a preferredembodiment of the invention, the proximal end of the shank contains apair of downwardly extending divergent, resilient legs which tend toprevent inadvertent expulsion of the device. In another preferredembodiment, the lower end of the device is formed with a small containerfor certain types of medication which are released gradually into thevagina over a prolonged period ottime for the prevention and cure ofsuch dis' eases as gonorrhea and syphilis.

30 Claims, 11 Drawing Figures U.S. Patent 0a. 21, 1975 Sheet 1 on3,913,573

US. Patent Oct. 21, 1975 Sheet20f3 3,913,573

U.S. Patent Oct. 21, 1975 Sheet 3 Of3 3,913,573

INTRAUTERINE CONTRACEPTIVE DEVICES WITH PLURAL PARALLEL LEG SEGMENTSREFERENCE TO RELATED CASE This is a continuation-impart of U.S. Pat.application Ser. No. 294,200, filed Oct. 2, I972, now abandoned.

BACKGROUND OF THE INVENTION 1. Field of the Invention The inventionrelates to both new and useful improvements in intrauterinecontraceptive devices.

2. State of the Art It has been known for many years that a foreignobject in the uterus will prevent conception. To date, many differenttypes of intrauterine contraceptive devices, aslo known as IUD's, havebeen proposed, and several types are in widespread use, but none havebeen fully satisfactory.

Bleeding and pain account for 85 per cent of the complications or sideeffects of intrauterine contraceptive devices. Therefore, any devicethat would reduce or eliminate bleeding and pain would lead to fewerremovals of intrauterine contraceptive devices for "cause," and wouldallow a greater percentage of patients to continue to use" the IUDs andwould proba bly also expand the usage of IUDs.

Lack of confidence in the IUDs, as a result of unnoticed spontaneousexpulsion of the device with the resulting potential for unwantedpregnancy or the improper positioning of the device resulting in a lossof the thread or threads in the uterus, contine to plague the presentlyavailable intrauterine contraceptive devices. When the tail of aconventional IUD cannot be seen at the cerivcal os, the physician isfaced with a dilemma, since he must make a distinction between unnoticedexpulsion, ascent of the tail into the uterine cavity and possibleperforation of the uterus. With presently available IUDs, in order todetermine their presence within the uterine cavity, the physician musteither send the patient for an X-ray, with its attendant exposure,radiation exposure, the possibility of the patient being pregnant, andadditional loss of confidence in the IUD by the patient, or probeblindly" in the uterus, with a sound, a long, thin metal instrument, andwith nothing to guide the sound this can become a painful, difficult andeven dangerous procedure.

Syphilis and gonorrhea can be extremely harmful diseases, if notcontrolled, and are of epidemic proportion. No adequate technique forpreventing these diseases has been demonstrated, although it iswell-known that certain antibiotics will kill the organisms that causethese diseases. Accordingly, it is extremely desirable to be able tokill any gonoccocus or syphilitic organism immediately as they aretransmitted in order to prevent either disease from developing in thehost, individual.

BRIEF SUMMARY OF THE INVENTION The invention comprises an IUD having ashank portion in which there is embedded a permanent magnet, the shankportion terminating at its distal end in a pair of convoluted loopshaving substantially transverse arms or arm segments with respect to theaxis of the shank and sinusoidal arms extending laterally from theshank. One of th convoluted loops may be longer than the other in theelongated position in which the loop is coextensived with the shank, andmay terminate in a bulbous end portion. In one embodiment, thetransverse arms are connected to the shank and the convo luted loopsdepend therefrom. In another embodiment, the convoluted loops areconnected to the shank and the transverse arms are connected to theouter ends of the respective convoluted loop members. Each of theconvoluted loops is substantially sinusoidal in configuration andcomprises at least three linear segments sub stantially parallel to theshank and connected by the transverse arm to the shank. The IUD isformed of a flexible thermoplastic material having plastic memory, sothat the convolutions may be straightened out and the IUD placed into anelongated tube for proper uterine insertion by a physician or othermedical professional.

In a preferred embodiment of the invention, the arms and convolutionsand a substantial portion of the shank are formed of or covered with athin coating of a material which does not cause foreign body reactions,even after prolonged periods of time, and minimizing bleeding fromcontiguous areas, such as a silicone rubber, to lessen the incidence ofany problems, such as bleeding, resulting by the residence of the IUD inutero.

In the preferred embodiment of the invention the proximal end of theshank terminates in a pair of downwardly extending divergent flexiblelegs, which serve to retain the IUD in place and prevent expulsion. Thelegs form an acute angle in the range from about 6 to about 30, andpreferably about 10. The proximal end of the shank, or, in the case ofthe preferred embodiment, the ends of the divergent legs, terminate in asmall nodular segment or segments to which a thin filament or thread isfastened to extend from the uterus into the vagina and provide atangible manifestation of the presence of the IUD in situ.

The permanent magnet which is incorporated in the shank of the IUDserves two functions. First of all, it prevents inadvertent expulsion ofthe IUD from the uterus because it is positioned at the top of theshank, thereby making the IUD top heavy and less likely to be expelled,and because the use of the magnet allows the IUD to be located by theuse of a ferrous sound or a magnetic or electromagnetic sound so thatthe physician, when he is probing in the uterus to locate the IUD willbe able to do so by virtue of the attraction of the ferrous or magneticor electromagnetic sound to the magnet incorporated in the IUD.

The IUD preferably has incorporated therein a suffi cient amount ofbarium or a barium salt to make the IUD radio-opaque whereby it may belocated by X-ray, if necessary.

In an embodiment of the invention, a medication, such as a topicalanesthetic or other pain relieving drug or an anti-fertility agent, maybe incorporated into the silicone rubber material of the IUD, and willbe leached out therefrom, to permit a controlled release of drug intothe uterus during the initial and subsequent periods of use of the IUD.

In an alternate embodiment of the invention, the convolutions of the IUDare wrapped with fine copper wire, in order to improve the efficacy ofthe IUD in pre venting conception.

In yet another embodiment of the invention, a small container for liquidmedication is formed within the shank portion of the IUD, preferably atits lower end, and terminating in a self-sealing globule which willgradually release the liquid medication into the uterus or vagina. Theshank can be formed to extend through the cervix into the vagina and cantherefore release medication directly into the vagina. This embodimentis particularly useful for the release of certain antibiotics, such aspenicillin, erythromycin or tetrocycline, which will prevent or curesyphilis and gonorrhea. The material of the globule, which permits thegradual re lease of medication therefrom, also permits the reseal ableintroduction of a fine hypodermic needle therein to refill the containerwith medication and thereby to avoid the necessity for removing the IUDand inserting a substitute IUD. The size of the globule, and theattendant rate of release of medication therefrom, can be varied torelease the minimal inhibitory concentration of antibiotic necessary toinhibit the growth of the particular gonococcal strain in the country ofuse, it being well recognized that strains in some geographic areasbeing more virulent than the gonococcus strains present in other areas.

OBJECTS OF THE INVENTION An object of this invention is to provide anintrauterine contraceptive device which is safe and effective incomparison to the prior art devices.

Another object of this invention is to provide an IUD which will spreadover most of the endometrial cavity and thus lessen the changes ofpregnancy.

Still another object of this invention is to provide an IUD which, onceplaced properly, will remain relatively fixed in its intrauterineposition and will not easily be expelled inadvertently, but which canreadily be removed when removal is desired.

A concomitant object of this invention is to provide an intrauterinecontraceptive device whose presence and proper position in the uteruscan be readily determined by the use of a ferrous, magnetic orelectromagnetic sound.

Another object of the present invention is to provide an IUD which isless likely to be expelled inadvertently than prior art devices.

Yet another object of the present invention is, when possible andmedically advisable, to provide an IUD construction which can beretrieved by an electromagnet in order to save the patient an abdominaloperation in cases of partial perforation of the uterus.

Still another object of this invention is to provide an IUD formed witha medically acceptable outer material to minimize uterine bleeding dueto a foreign material in the uterus.

Yet another object of this invention is to provide an IUD constructionwhich incorporates topical anaesthetics, steroids or medicaments, whenmedically advisable, in the material of the IUD for the slow release ofpain relieving drugs or anaesthetics in utero.

It is similarly an object of this invention to provide an IUD which isof unique mechanical design, which can be worn with comfort for years,and then easily removed without discomfort to the patient.

A further object of this invention is to provide an IUD that may bepresterilized, that lends itself to easy insertion into the uterus withthe help of a simple instrument, and that will not interfere with eithermenstruation or vaginal function.

An additional object of this present invention is to provide an IUDwhich a nulliparous patient can use effectively with no or minimaldiscomfort, thereby to expand the number of potential users of IUDs.Another object of this invention is to provide an IUD that will releasemediation into the uterus or vagina at a con trolled rate over aprolonged period of time for the prevention or treatment of diseases.such as syphilis and gonorrhea.

Yet another object of this invention is to provide an IUD that willrelease medication directly into the vagina and can be refilled withmedication without removing the IUD from the vagina.

DESCRIPTION OF THE DRAWINGS FIG. I is a front elevational view of theIUD of this invention, located in the tubular insertion device andinserted in the uterus for introduction of the IUD in utero;

FIG. 2 is a front elevational view of the preferred em bodiment of theIUD of this invention, located in utero in its position of use;

FIG. 3 is a view, similar to FIG. 2, showing a second embodiment of theinvention;

FIG. 4 is a view, similar to FIG. 3, showing yet another embodiment ofthe invention;

FIG. 5 is a cross-sectional view, taken along line 55 of FIG. 1;

FIG. 6 is a cross-sectional view, taken along line 66 of FIG. 3;

FIG. 7 is a front elevational view of the preferred embodiment of theinvention, and the insertion device, as packaged prior to use;

FIG. 8 is a front elevational view, similar to FIG. 2, showing yetanother embodiment of the invention where the convoluted loops arefastened directly to the shank;

FIG. 9 is a view similar to FIG. 8, but including means for thesustained release of liquid medication;

FIG. 10 is a partial cross-sectional view of yet another embodiment ofthe invention, similar to that of FIG. 3, but including means for thesustained release of liquid medication; and

FIG. 11 is a view similar to FIG. 10, but with an elongated shankentending through the cervix for the direct release of medication intothe vagina.

DETAILED DESCRIPTION OF THE INVENTION Viewing FIG. 2, the preferredembodiment of the intrauterine contraceptive device of this invention,which is generally designated by numeral 10, is seen to comprise -athin, elongated central stem or shank 16, of generally rectangularcross-section with rounded corners, although this shape may also beelliptical or oval. At the proximal end 18 of the shank 16, there isformed a pair of downwardly extending, divergent flexible legs,respectively designated by numerals 20 and 22. The legs are preferablyintegrally formed with the shank l6, and extend at angles in the rangefrom about 3 to about [5", and preferably about 5, with respect to thevertical. Therefore, the angle between legs 20 and 22 is in the rangefrom about 6 to about l5 and is preferably about IO". At the proximalextreme of each of the two legs 20 and 22 is located an eye or nubbin,respectively designated as 24 and 26, to which filaments or tails,designated by the letter T, are fastened, as by knotting, through anaperture therethrough, fusion, or by means of a suitable medicallyacceptable adhesive.

Embedded within shank 16 is a permanent magnet 28, which, in thepreferred embodiment, occupies at least 50% of the length of the shankl6, and preferably occupies approximately the upper two-thirds of thelength of the shank I6. The permanent magnet also occupies at least 80%of the cross-section of shank 16, in the preferred form of theinvention, so that the thermoplastic material of shank 16 only providesa thin cover ing layer for the permanent magnet 28.

The distal end 30 of the intrauterine device is integrally formed with apair of divergent arms 32 and 34, which extend in a transverse directionwith respect to the axis of shank 16. Each of the arms 32 and 34 is apart of a convolute or loop section, respectively designated by numerals36 and 38. Viewing convolute sec tion 36, it is seen to comprise the arm32, a depending leg 40 connected to arm 32 by curved section 42, andupwardly and substantially vertically extending leg 44 connected to leg40 by curved section 46, a depending leg 48 connected to leg 44 bycurved section 50, and an upstanding leg 52 connected to depending leg48 by a curved section 54. Leg 52 terminates at its free end in anenlarged bulbous extremity or nodule 56, which may be of spherical ordisc-shaped configuration, the purpose of which will be explainedhereinafter.

Viewing convolute section 38, it is seen to comprise the transverse arm34, which is connected by arcuate section 58 to depending leg 60, whichis, in turn, connected by arcuate section 62 to upstanding leg 64.Upstanding leg 64 is connected by arcuate section 66 to depending leg70.

It is to be noted that the corresponding legs of the convolute sections36 and 38 of approximately the same length, but what convolute 36 has anadditional leg section 52 and connecting section 54, not present inconvolute 38. Accordingly, when the convolute sections are stretched outto be substantially conextensive with the longitudinal axis of shank l6,leg 52 and its enlarged bulbous end 56 will extend beyond the leg 70.The purpose of having this longer leg and bulbous end is to facilitatethe insertion of the IUD into the insertion member and its subsequentproper placement in the frontal plane of the uterine cavity. The bulbousend 56 is of greater cross-section than the aperture in the insertionmember, which is described below, and prevents the IUD from being drawncompletely into the insertion member. Bulbous end 56 also, because ofits smooth and round leading edge, facilitates insertion of the IUD intothe uterus and minimizes the likelihood of irritation of the walls ofthe cervical canal and of the uterus during the placement of the IUD Inthe preferred form of the invention for a patient, the shank 16 has alength of approximately 16 mm., a width of approximately 4 mm. and adepth of approximately 2.5 mm. Each of the legs and 22 has a length ofabout 8 mm., a width of 2mm. and a depth of 2.5 mm. The over-alldimensions of the IUD unit in situ are about 38 mm. wide and 26 mm.high. The permanent magnet 28 is 9 mm. long and 3 mm. in diameter.However, the dimensions given are for general guidance only, and may bevaried to suit the needs of the patient and to accommodate best thelargest number of patients.

Each of the convolute sections, in cross-section, has a rounded-cornerrectangular configuration, and has a width of 2 mm. and a depth of 2.5mm., and when straightened out so that the convolute legs aresubstantially coextensive with shank 16, the entire unit has a length ofapproximately 100 mm.

For a nulliparous patient, the IUD of this invention would preferablyhave somewhat different dimensions.

The permanent magnet would be of 2 mm. or less diameter, so that shankI6 would be about 2.5 mm. wide. The entire IUD unit would occupy a widthof about 26 mm. and a height of about 26 mm.

The filaments or tails T are preferably round in shape, about 0.2 mm. indiameter and about 100 mm, in length and are preferably extrusions ofnylon, polyethlene, polytetrafluoroethylene or other flexible, medicallyacceptable material. The tails T may be fastened to the nubbins 24 and26, by tying, adhesive or fusionv The length of each of the filaments Tis such that a substantial amount of residual length can be cut afterthe IUD is inserted so that a string of about 75 mm. remains in thevagina.

The foregoing dimensions as to the IUD device of this invention are notcritical, but are optimum from a prac' tical standpoint for proper, snugfit of the IUD in the endometrial cavity, and may be modified to suitthe characteristics of the patients to be using the IUDs of thisinvention. However, it is to be noted that the IUD of this invention isdesigned to have minimum bulk to insure minimum likelihood of pain ordiscomfort on insertion. It is noteworthy that the IUD must besubstantially planar in configuration, to allow it to conform properlyto the shape of the uterus, which is thin and flat.

The shape of convolute sections 36 and 38 is of par ticular importancein the invention because it conforms substantially to the configurationof the endometrial cavity and spreads to occupy most of the endometrialcavity. Thus, the outer legs 40 and 60 and transverse arms 32 and 34 ofthe respective convolutes 36 and 38 should be substantially straight toconform to the shape of the walls of the endometrial cavity. The innerlegs of convolutes 36 and 38, that is to say, legs 44, 48 and 52 ofconvolute 36 and legs 64 and 70 of convolute 38, are preferablysubstantially straight and parallel to shank [6. However, it is withinthe purview of this invention for those legs to be somewhat curved inconfiguration, the primary consideration being the necessity foroccupying the maximum portion of the endometrial cavity.

Although the shank, legs, and convolute sections of IUD 10 arepreferably of rounded corner rectangular cross-section, it is within thepurview of this invention for these elements to be of oval or ellipticalor other non-circular cross-section. Non-circular cross-section isdesirable to insure that the IUD may properly be located in thecorrespondingly shaped insertion unit, to allow the IUD readily to beplaced in the frontal plane of the uterus.

The intrauterine contraceptive device 10 is preferably formed of aresilient, biologically inert, medially acceptable material havingplastic memory, i.e. resistance to cold flow, so that the device willresume its convoluted shape after it has been held in the elongatedposition in the insertion device for a resonable period of time. Thematerial of choice is polyethylene, and a selection of medicallyacceptable polyethylene of optimum molecular weight and othercharacteristics is within the purview of the skilled artisan. In moldingthe intrauterine device of this invention, it is desirable to add about10% or more by weight of barium or a barium salt, in order to make theintrauterine device radioopaque, whereby it may be viewed by X-ray, inthe event that the exact location of the IUD is required to bedetermined.

The device is preferably covered, at least in areas other than thoseimmediately overlying the magnet 28, with a thin layer ofa medicallyacceptable silicone elastomer, such as Silastic, a product of DowChemical Company. It is also within the purview ofthis invention toincorporate medicaments, such as local anesthetics, and anti-fertilityagents, such as steroids, in effective quantities into the siliconeelastomer sheeting or coating which may then be leached out for gradualrelease into the uterus, in instances in which the introduction of suchmaterial is desirable. safe and efficacious.

When its is desired to incorporate a topical anes thetic into theSilastic, lidocaine, also sold under the trademark Xylocaine, is theanesthetic of choice. This anesthetic may be used in concentrations ofup to 4% by weight, but is preferably in concentrations of lor 2 byweight. This anesthetic is stable and boilable, non irritating totissues, and the onset of anesthetic effect is immediate, diffusingrapidly into the tissues. The typical dose would maintain the anestheticeffect for about 1 to PA hours.

It may be desired to desensitize both the cervical canal and theendometrial cavity prior to the insertion of the IUD of this invention,particularly in a nulliparous patient. This can conveniently be achievedby introducing or instilling about l cc. of l or 2 weight percentXylocaine solution into the cervical canal and introducing or instillingabout 2 to 4 cc. of Xylocaine solution into the uterine cavity. Asuitable presterlized syringe, containing the proper concentration ofanesthetic solution may be packaged in the same sterile sealed packageas the intrauterine device.

The electrical activity of the human uterus in the presence of an IUDhas been measured, and it has been determined that there is markeduterine activity shortly after the introduction of the IUDv Increaseduterine activity has been noted at the time of ovulation, andparticularly at the time of menstruation. This is why the expulsion ofan IUD is most likely to occur after or during menses.

The use of an anesthetic incorporated in the IUD of this invention canbe quite helpful in reducing the frequency of expulsion of IUDs, aprimary cause of ineffectiveness of IUDs in many patients. Irritation ofthe cervix and/or uterus upon insertion of the IUD, and the pain ofdiscomfort associated therewith, substantially increases the likelihoodof expulsion of IUDs. Therefore, incorporation into the siliconeelastomer ofa sufficient amount of a local anesthetic, such as Lidocaineor Xylocaine will desensitize the cervix and uterus for a sufficientperiod of time after insertion of the IUD in utero to reduce thelikelihood of IUD expulsion.

When it is desired to incorporate medication into the siliconeelastomeric material of the IUD, this may be done in one ofthree ways.Ifthe IUD is constructed primarily of a material such as polyethylene,the shank and other parts of the IUD may be covered with a sheet orspray coating of medical grade Silastic elastomer in which themedicament has been incorporated, in a matter to be discussedhereinafter. Alternatively. the shank of the IUD, or the entirely of theIUD, may be formed of medical grade Silastic elastomer, having themedicament incorporated therein.

Suitable medicaments for incorporating into the silicone elastomericmaterial are local anesthetics, such as Xylocaine or Lidocaine, oranti-fertility agents, such as progesterone or medroxy progesteroneacetate. If one of the progestogens is incorporated into the siliconeelastomeric material, medication is released during the first few daysof residence of the IUD in utero at a fairly rapid rate, and after thefirst few days of residence the drug continues to be released at a muchslower, relatively constant rate for a prolonged period of time. Othersteroids, such as estradiol, testostrone, cortisol and androstenedione,which are the more polar ste roids, may also be used, but they are notreleased at as high a rate as the less polar steroids.

The medicament can be incorporated into the sili cone elastomer byadmixing with the silicone elastomer when it is in a fluid state, andsubsequent formation of the amorphous or fluid elastomer into theelement of the IUD by extrusion, die casting, or the like. Alternatively, the medicament may be incorporated in the elastomer, when theelastomer is in the fluid state, and sprayed in a fluid state onto allor selected portions of an IUD of a different material, such aspolyethylene.

An alternative method for insertion of the medication is to place anamount in the range form between 50 to 500 milligrams of the medication,in the form of milled crystals, within a hollow tube ofthe siliconeelastomeric material of medical grade. Such a tube would constitute allor part of the shank of the IUD of the invention, but the tube wouldhave an outside diameter not substantially in excess of 3 to 4millimeters, The open end of the tube would be sealed with a medicalgrade adhesive, such as a silicone rubber adhesive. The medication wouldthen be leached out through the sillcone elastomeric walls of the hollowtube. It is important to note that the rate of passage or diffusion ofthe medication through the Silastic wall is not influenced by the weightof medication contained therein; rather, its releases are dependent uponthe surface area and wall thickness of the elastomric material. That isto say, more medication will pass through a long tube than a short tube,and for a given amount of surface area, sub stantially moe medicationpasses through a thin wall of material than through a thicker wall. Thethickness of the wall and the surface area of the elastomeric tube canthereby be controlled in dimension to control the rate of release ofmedication.

It is also within the purview of this invention to incorporate more thanone medication into the material of the invention, in different sectionsof the IUD of this invention, in order to provide for the controlled release, at different rates if desired, of different medica tions.

Also, to increase the efficacy of properly situated IUDs, the siliconeelastomer can include a sufficient amount of an anti-fertility material,as noted above. This would be released uniformly and gradually during aprolonged period of time of months or even years and further increasethe efficacy of IUDs in preventing conception. The advantage of thisuterine introduction of anti-fertility agent over oral ingestion is thathe oral form requires daily usage and motivation and can be forgottenor "skipped".

It is also within the purview of this invention to con struct the IUDtotally of a silicone elastomer of suitable resilience, flexibility andplastic memory, and which is medically acceptable and biologicallyinert, has a low hemolysis index and non-wetting surface property. Thenon-wetting surface helps to reduce incrustation with calcium salts,such as calcium carbonate, and consequent clotting, which is somewhat ofa problem when polyethylene is used.

The inserting instrument, for inserting the IUD of this invention intothe patient, is best seen in FIG. 7. The inserting instrument itself,which is generally designated by numeral 80, comprises an elongatedhollow tube 82 and a plunger member 84 for discharging the IUD 10 from aposition within the tube 82 into the uterus.

The tube 82, in the preferred embodiment, is approximately 196 mm. formthe distal end 86 to the finger rest 88 which is located at the proximalend of the tube 82. Mounted peripherily about the tube 82 and spacedapproximately 45 mm. from distal end 86 is a horizontal flange 90, thepurpose of which is to limit the degree of insertion of the tube intothe uterus, to prevent excess penetration of the insertion instrumentand possible harm to the patient. The plunger 84 comprises a stem 92, apiston 94, mounted at the distal end of the stern, and a handle 96,mounted at the proximal end of the stem. The proximal ends of filamentsT are fastened to stem 92 or piston 94 of plunger 84, as by tying,fusion or a suitable adhesive and a substantial length of filaments Tresides alongside stem 92 of plunger 84 and readily unwinds as theinserting device is removed from the uterus after the IUD I is inserted.A clearance is provided between plunger piston 94 and the inner diameterof insertion tube 82 to permit easy movement of the plunger in the tube,thereby allowing for the presence of the filament therein.

The tube 82 and piston 94 of plunger 84 are preferably of rounded-cornerrectangular cross-section, having a width of about 6 mm. and a depth ofabout mm. and a wall thickness of about 0.5 mm. The piston 94 of plunger84 has a width of about 3mm., a depth of about 2 mm. and a length ofapproximately 202 mm. The foregoing dimensions are optimum, but are notcritical, and will be varied to accommodate the particular shape anddimensions of the IUD being inserted. For exam ple, if the IUD I0 is ofelliptical cross-section, the insertion tube 82 and piston 94 will alsobe of elliptical cross-section.

The inserting instrument 80 is desirably molded of a medicallyacceptable material, such as medical grade polytetrafluoroethylene.

In practice, the IUD 10 is packaged in package 12 with the insertinginstrument 80, in the manner shown in FIG. 7, but preferably not withthe proximal end of the preferred embodiment of the IUD partiallyinserted into the distal end of 86 of tube member 82. The reason for notinserting the IUD [0 into the tube in packaging, is to avoid any loss ofplastic memory of the convolute section 36 and 38 and the legs and 22 ofthe IUD.

The IUD and inserting device are packaged in a hermetically sealed,sterilized container 12, of a well known type of material and in amanner which is wellknown in the art, such as by forming the container,evacuating the container, replacing the interior of the container with asterilizing atmosphere such as ethylene oxide gas, evacuating that gasand then completing the sealing of the container.

In use, the IUD of this invention is inserted as follows. The usual timeperiod for the insertion of the intrauterine device would be during thelast day or two of a normal menstrual period. Prior to inserting theIUD, the physician or other medical professional, by history and pelvicexamination of the patient would consider the contraindications to itsuse. The most important such contraindications are suspicion ofpregnancy or actual pregnancy, acute cervicitis, acute salpingitis,suspected carcinoma, distortion of uterine cavity by fibroids, septateor bicronuate uterus, or menorrhagia or unexplained bleeding. When noneof the containdications to the use of the IUD is present, the patient'slegs are inserted in stirrups on the examining table in the usual pelvicexamination position, and the physician may do another pelvicexamination to confirm the size and po sition of the uterus and confirmthe diagnosis of ante flexion or retroflexion and the depth of theuterine cavity. Subsequently, the cervix would be cleaned with anantiseptic solution, applying a long (190 mm.) tenaculum to the anteriorlip of the cervix and sounding the uterus with a sterile sound. Prior todilating and/or sounding, a sterile local anesthetic may, if desired, beapplied to the cervix and cervical canal to eliminate discomfort.

For insertion of the intrauterine device, the sterile package 12 wouldfirst be opened by the physicians or medical professionals assistant.Using sterile gloves, the insertion device would be held in one hand,and the other hand would compress and insert the legs 20 and 22 of theIUD 10 into the open distal end of tube 82. Plunger 84 would then bepulled outwardly, so that the filaments T, which are attached at one endto IUD l0 and at the other end to the plunger 84, and the slack of whichis located beside stem 92, would be used to pull the body of theintrauterine device 10 down into the tube 82. The plunger would bepulled inwardly until all but the bulbous end 56 of the intrauterinedevice 10 has been drawn into the tube 82, making sure that both the IUDand the flat surface of the insertion tube flange are in a horizontalplane, to insure proper placement of the IUD in the frontal plane of theuterine cavity. Of course, when located in the insertion tube, theconvolute sections 36 and 38 of the intrauterine device 10 would bestraightened out and would be substantially coextensive with shank 16.Preferably, the IUD I0 is not inserted into the insertion tube 82 untilone or two minutes prior to use, in order not to interfere with thememory" of the intrauterine contraceptive device.

The tenaculum would be slightly pulled on by the physician to straightenout the uterine canal and give a slight counter-pressure. Gently andslowly, the insertion device 80 would be inserted into the cervical osuntil the flange 90 reaches the anterior edge of the cer' vical os andthe insertion device is in the position shown in FIG. I. The plunger 84is then pushed gently and slowly into tube 82, as far as it will go. Asthe IUD I0 is introduced into the frontal plane of the uterine cavity bythe movement of plunger 84, it regains its original configuration, asillustrated in FIG. 2 and is properly emplaced within the uterinecavity. The inserting unit 80 is then withdrawn from the cervical canal,and the tail T of the IUD is pulled out from along side stem 92 is thencut, leaving approximately 75 mm. of the tail attached to IUD 10 andextending into the vagina.

Of course, any instruments used to assist in the insertion of the IUDshould be removed. Once the IUD has been properly inserted, the patientslegs may be straightened out, and the patient should be allowed to restfor a few minutes after the insertion.

In the event that the IUD is desired to be removed at any time, thephysician my grasp the proximal end of the tail T with a uterinedressing forceps or sponge for cups, and pull outwardly with steadily,gentle force. This would tend to pull the legs 20 and 22 of the IUDinwardly, so that the IUD can gently be withdrawn from the uterus. Theconvolutes 24 and 26 will straighten out, for ease of withdrawal, as theIUD is pulled through the cervix.

The IUD 10 illustrated in FIG. 3 is identical to the IUD 10 of FIG. 2,with the sole exception that the shank I6 terminates, at its proximalend 18, in a small round nubbin 24', to which the filaments T are tiedor otherwise fastened. Therefore, IUD 10' does not have divergent legswhich assist in preventing its accidental expulsion. In use, the IUD 10of FIG. 3 is handled in the same manner as the IUD of FIG. 2, with theexception that it may be desired to package the IUD 10' with the shank16 extending into tube 82 of the inserting de vice, so that all that isrequired to be done to complete insertion of the IUD into the insertingdevice is to pull outwardly on knob 96 of plunger member 84 tostraighten out convolute sections 36 and 38 draw them into tube 82.

In the embodiment of FIG. 4, it will be seen that legs 40" and 60" ofthe respective convolute sections 36" and 38" of IUD I" are wrapped withcopper wire 100. Copper wire 100 is of about 0.l mm. diameter, and is ofa length to provide at least 100 millimeters of surface area on eachleg. The copper wire 100 is wound on each of the two legs 40" and 60" ina spiral winding. The function of the copper wire is to enhance thecontraceptive effect of the IUD by inhibiting implantation of theblastocyst and by the tendency of copper to inactivate spermatoza.Although copper wire is shown only on legs 40" and 60", if a greateramount of copper wire is desired, it may be wound on other segments ofthe convolutes 36" and 38". The copper wire may, if desired, be would onother legs of the convolutes, instead of legs 40" and 60".

In the use of the IUD of this invention, in the event that the physicianis attempting to locate the IUD, and the tail T has accidentally beenlost, the physician may locate the IUD inutero, without the need forX-rays, by the insertion of a ferrous sound, a well known instrument,into the uterus and by detecting, by feel, the pull of the permanentmagnet 28 on the ferrous sound. An electromagnet or a magnetic sound ofreverse polarity from that of the proximal end of magnet 28 may also beused to facilitate the location and the removal of a "lost" IUD or,under certain conditions, an IUD which has pierced the wall of theuterus.

The embodiment of IUD illustrated in FIG. 8 is substantially identicalto that illustrated in FIG. 2, with the sole exception that there is notransverse arm connecting the convoluted portions to the shank, and oneof the convoluted portions does not end in a bulbous member. Rather, inthe embodiment of FIG. 8, IUD 10 is formed of a shank member 16, whichis identical with the shank member illustrated in FIG. 2, and containsembedded therein the permanent magnet 28. Shank 16 terminates at itslower end in the bifurcated legs 20 and 22, which have apertures formedtherein through which the threads T are fastened to extend from theuterus into the vagina, to facilitate removal of the IUD.

The IUD 10" possesses two transversely extending arms I02 and 104, butunlike the counterpart arms of FIG. 2, these are not directly connectedto the shank 16. Rather, the outer ends ol'the arms I02 and 104 areconnected to the convoluted loop sections, generally designated I06 andI08, each of which comprises four interconnected vertical segmentsdesignated 110, I12, H4 and 116. The vertical section 116 which iscloseest to the shank is connected to the shank by connecting member118.

The embodiment of FIG. 8 functions in the identical manner as that ofFIG. 2, the convoluted portions being capable of straightening out whenthe IUD is inserted in the applicator for insertion into the uterus. Theconvoluted portions 106 and 108 fill the uterus in the same optimalfashion as described with respect to the embodiment of FIG. 2, andbecause more convolutes are present in this embodiment, do a somewhatbetter job of filling the uterus. It will be appreciated that the end ofhorizontal members 102 and 104 will have to be curved, so as not topresent any sharp surface which will in any way damage the uterus.

The embodiment of FIG. 9 is identical with that of FIG. 8, except thatthe shank contains a shorter magnet formed therein to allow for themedicament container which is formed within the IUD itself. Themedication container is formed as a latex sleeve 122 located and formedin the bottom portion of the shank l6, and teminating in the globuleportion I24 which extends beneath the shank and between the arm 20 and22.

FIG. 10 illustrates another embodiment of the invention, similar to thatillustrated in FIG. 9, except that the IUD does not terminate inbifurcated arms. Rather, in the manner illustrated in FIG. 3, the IUDmerely terminates in the elongated shank. FIG. I0 better illustrates themanner in which the medication container 122 is formed in the end of theshank 16. It will be appreciated that the incorporation of the containerinto the shank of FIG. 10 is substantially the same as its incorporationinto the shank of FIG. 9, with the exception that in the embodiment ofFIG. 9, the globule is partly seated in suitable cut-outs from thebifurcated arms 20 and 22. Moreover, it is to be understood that theembodiment of FIG. 10 can be used with either of the arm configurationsillustrated in FIG. 2 and FIG. 8.

The medicament container 122, which is formed in shank 16 has anelongated cylindrical portion 132, which is formed of latex. At thelower end of the cylindrical section 132 is the globular section 134,which is formed of Silastic material, the silicone elastomer describedabove. The medicament container may be prefilled with medicament. priorto insertion into the shank of the IUD, such as by leaving the upper endof the container open, and subsequently capping it with an end cap oflatex which is heat or solvent sealed closed. Alternatively, because theSilastic material is resealable, after the container has been insertedand mounted or formed in the IUD, the medicament can be introduced intothe container 122 by the introduction of a fine hypodermic needle intothe Silastic globuel 134 for the purpose of introducing the appropriatequantity of medication, of the desired concentration, into the globule.The latex container portion may be pre-formed and mounted in the shankby the use of a suitable adhesive or solvent.

Because of the unique characteristic of the Silastic material, it willgradually release medicament contained in the container 122 into thesurrounding body cavity. Therefore, in the embodiment illustrated inFIG. I0, whatever medicament is contained within the container 122 willbe released into the mouth of the womb proximate the entrance of theuterus. A certain amount of this medication will migrate through thecervix into the vagina in the normal body fluids.

The use of the IUD containing medication in prolonged release form isparticularly desirable from the standpoint of the prevention and cure ofveneral diseases, such as syphilis and gonorrhea, which are extremelywidespread, and which present an enormous health of epidemicproportions. It is well known that syphilis and gonorrhea organisms canbe killed or controlled by the use of suitable antiobiotics orantibacterial agents, such as penicillin, erythromycin, and Rima tane,tetracycline, doxycycline and getamycin. Thus, by the gradual release ofone of these antibiotics in situ, the syphilis or gonorrhea organismspresent in the vagina or the uterus will be killed by the medicationbefore they have an opportunity to grow.

The container 122 is filled with a quantity and concentration of asuitable antibiotic or antibacterial agent which will provide acontinuous and sustained release of the agent during a period of about Ito about 6 months, it being understood that the instantaneous amount ofagent released from the container need only be small, because of thecumulative effect of the release over a substantial period of time.

The rate of release and duration of release of the medicament can becontrolled by regulating the concentration of the medicament, the volumeof medicament in the container 122, the size of the surface area ofglobule 134, and the thickness of the globule wall. Thus, these factorscan be varied to suit the particular needs of the patient to provide forgiven rates of release and periods of release of the variousmedications.

In addition to the antibiotics described, it is also within the purviewof this invention to incorporate in the container 122 an acid, such aslactic acid, which is known to be hostile to the gonococcus but is notinjurious to the patient.

It is to be noted that with respect to any of the medicaments utilized,it will be necessary to have present in the vagina the minimuminhibitory concentration of the medication sufficient to use theinactivation or inhibition of the growth of the gonococcus organism orto cause its destruction or disintegration. Among the various gonococcusstrains, the resistance of these strains to various medications canvary. In particular, the strains present in the Far East, such as theNeisseriae gonococcus are more resistant to treatment by medication thanare the organisms which are indigenous to the western hemisphere.Accordingly, with respect to the more resistant organisms, it will benecessary to present a greater concentration of medication in container122. It will, therefore, be appreciated that, when the IUDs of theinvention are manufactured for use in different countries, they would bemanufactured with a construction and medication which is designed torelease the minimum inhibitory concentration of medication for theparticular gonococcal organism in the area in which the IUD is to beused.

Once the IUD has been inserted in the uterus of the user, the medicationin the container will be distributed during a period of from 1 month to6 months or even 1 year. The particular period of release will beindicated on the package for the IUD, so that the physician can knowwhen the effect of the medication will cease, and will advise thepatient that it will be necessary to come into the physician's officefor a reintroduction of medication into the IUD a reasonable period oftime before the exhaustion of the contents of the container. Because theSilastic can be manufactured to be self sealing, new medication can beintroduced by the physician by the utilization of a hypodermic syringecontaining the desired volume of medication, and using a relatively fineneedle, such as a 24, 25 or 26 gauge hypodermic needle. A hypodermicsyringe with an appropriate size of needle and containing the necessarymedication, in a quantity sufficient to fill the container 122 of theIUD can be prepackaged for disposable use for this purpose. In theinstance of the embodiment illus trated in FIG. 10, the physician, inorder to introduce the medication into the globule, would have to inserta vaginal speculum into the patient to expose the surface of the IUD,and pull down gently on the vaginal filaments T of the IUD until theglobule I34 is exposed. The surface of globule 134 would then be paintedwith a suitable antisetpic solution, such as aqueous Zephiran orBetadine solution, after which the hypodermic sy ringe could be utilizedto recharge the container 122 of the IUD.

FIG. II shows yet another embodiment of the invention which avoids someof the limitations of FIG. 10, in that the embodiment of FIG. 11contains an elongated shank having a section 138, which is part of theshank, and which extends through the cervix and opens into the vaginalcavity itself. The outer diameter of this elongated section 138 issomewhat less than the outer diameter of the upper portion of the shank16, which resides in utero, and the proximate end of the extension 138extends into the vagina. Similar to the embodiment of FIG. 10, this IUDcontains a latex container 140 for a suitable medication, and, becauseof the greater length of the extended shank 138, is capable of holding asubstantially greater amount of medication for re lease into the vagina.As is seen in FIG. I], the globule 142 of Silastic material located atthe proximate end of the shank extention 138 extends into the vagina, sothat the medication for the control of the gonococcus or syphilisorganism is more readily available in the vagina itself for purpose ofkilling the organism before it enters the cervix and to insure a maximumconcentration of medication in the vagina per se.

The embodiment of FIG. 11 facilitates the introduction of additionalmedication into the container in the situation where the container isexhausted or almost exhausted, because with this embodiment it is notnecessary to pull the IUD down from the cervix to expose the globulebelow the entrance to the cervix. Consequently, when it is desired torefill the embodiment of FIG. 11, it is merely necessary to cleanse theglobule 142 with an antiseptic solution and subsequently to inject thecharge of refill medication into the container.

It is to be noted that both embodiments of FIGS. 10 and I1 retain,located within the shank, the magnet 28, as described above, for thepurpose of facilitating the location of the IUD, in utero, with the useof a ferrous sound.

It will be appreciated that numerous modifications and permutations ofthe invention disclosed herein may be made without departing from thespirit of scope of the instant invention. For example, other materialshav ing similar properties to those disclosed herein may be usedefficaciously.

What is claimed is:

1. An intrauterine contraceptive device comprising:

a. a thin, elongated body member having a longitudinal axis, a proximalend and a distal end;

b, a pair of arms extending substantially transversely with respect tosaid axis, each arm having an outer end;

c. each of said outer ends terminating in a convolute member whichextends downwardly toward the proximal end of said body member andinwardly toward said body member and having a connecting sectionconnecting each convolute member to said body member;

(1. each of said convolute members including at least three substaniallyelongated leg segments substantially parallel to said body member andconnected to substantially arcuatc segments; and

e. said body, arms and convolute members being formed of a flexiblethermoplastic material.

2. An article as set forth in claim I, wherein said body member includesa container portion, integral there with and formed of latex, saidcontainer portion opening to the surface of said body member andterminating in an enlarged globular member of silicone elastomericmaterial capable of releasing therefrom uniformly and gradually over aprolonged period of time a medicament contained therein, said containerportion being capable of being refilled by the introduction ofmedicament therethrough from a hypodermic syringe.

3. An article as set forth in claim 2 wherein said body member is ofsuch length that it can extend through the cervix while the convolutemember is seated in the uterus.

4. An article as set forth in claim 2, wherein said container is filledwith a medically acceptable solution of an antiobiotic or antibacterialagent for the prevention, treatment or cure of the syphilis or gonorrheaorganisms.

5. An article as set forth in claim 1, wherein the proximal end of saidbody member terminates in a pair of downwardly extending divergent,flexible legs.

6. An article as set forth in claim 5, wherein each of said legs is atan angle of approximately 5 with respect to the axis of said bodymember.

7. An article as set forth in claim 5, including at least two strands ofthin, flexible material, each having a dis tal end, and means fasteningthe distal end of a strand to the proximal end of each of said legs,

8. An article as set forth in claim 1, wherein said body memberincludes, as an integral part thereof, an elongated member of a magneticmaterial occupying at least one-half of its length and at least 80%ofits crosssection.

9. An article as set forth in claim 8, wherein said magnet is locatedproximate the distal end of said body member.

10. An article as set forth in claim 1, wherein said arms extend in adirection which is substantially transverse to the axis of said bodymember, and said convo lute members having outer legs which aredependent from said arms, said convoluted members being generallysinusoidal in configuration.

11. An article as set forth in claim 1, wherein at least the surface ofsaid arms, said convolute members, and a substantial portion of saidbody member are covered with a silicone elastomeric material.

12. An article as set forth in claim 1, wherein said article is formedofa medically acceptable material having plastic memory, whereby saidarms aand convolute members may be deformed to be substantiallycoextensive with the axis of said body and will, after such deformatron,return to their original configurations.

13. An article as set forth in claim 1, wherein each of said body memberand convolute members are of rounded edge non-circular cross-section.

14. An article as set forth in claim 1, including a thin copper wirecovering at least a portion of each of said convolute members, each ofsaid copper wires having a surface area of at least millimeters.

15. An article as set forth in claim 1, wherein said thermoplasticmateriai includes a radio-opaque material incorporated therein.

16. An article as set forth in claim 1, including at least one thin,flexible strand of material having a distal end, and means fasteningsaid distal end to the proximal end of said body member.

17. An article as set forth in claim 1, wherein at least a portion ofthe surface of said article is formed of medically acceptable siliconeelastomeric material having incorporated therein for controlled releasein utero at least one compound selected from the group consisting ofanesthetics, analgesics and anti-furtility agents.

18. Apparatus as set forth in claim 1, wherein said body member hasmaximum outside diameter of about 4 mm.

19. An intrauterine contraceptive device comprising:

a. a thin, elongated body member having a longitudinal axis, a proximalend and a distal end;

b. a pair of divergent arms connected to the distal end of said body,each of said arms terminating in a convolute member which extendsdownwardly toward the proximal end of said body and inwardly toward saidbody member;

c, each of said convolute members ending in a free end proximate saidbody member, one of said free ends being closer to said body member thanthe other and comprising a bulbous member;

. each of said convoluted members including at least three substantiallyelongated leg segments substantially parallel to said body member andinterconnected by arcuate segments; and

e. said body, arms and convolute members being formed of a flexiblethermoplastic material 20. An intrauterine contraceptive devicecompaising:

a. a thin, elongated body member having a longitudinal axis, a proximaiend and a distal end;

b. a pair of short connecting arms connected to the distal end of saidbody member, each of said arms terminating in a convolute member whichextends downwardly toward the proximal end of said body and outwardlyfrom said body member;

c. each of said convolute members ending in a free arm remote from saidbody member and extending inwardly toward said body member proximate thedistal end thereof;

d. each of said convoluted members including at least threesubstantially elongated, substantially linear leg segments substantiallyparallel to said body member and interconnected by arcuate segments; and

c. said body, arms and convolute members being formed of flexiblethermoplastic material.

21. An article as set forth in claim 20, wherein the proximal end ofsaid body member terminates in a pair of downwardly extending divergent,flexible legs.

22. An article as set forth in claim 21, wherein each of said legs is atan angle of approximately with respect to the axis of said body member.

23. An article as set forth in claim 20, wherein said arms extend in adirection which is substantially transverse to the axis of said bodymember, and said convolute members have outer legs which are dependentfrom said arms. said convoluted members being generally sinusoidal inconfiguration.

24. An article as set forth in claim 20, wherein at least the surfacesof said arms, said convolute members, and a substantial portion of saidbody member are covered with a silicone elastomeric material.

25. An article as set forth in claim 20, wherein said article is formedof a medically acceptable material having plastic memory, whereby saidarms and convolute members may be deformed to be substantiallycoextensive with the axis of said body and will, after such deformation,return to their original configurations.

26. An article a set forth in claim 20, wherein each of said body memberand convolute members are of rounded edge non-circular cross-section.

27. An article as set forth in claim 20, wherein at least a portion ofthe surface of said article is formed of medically acceptable siliconeelastomeric material having incorporated therein for controlled releasein utero at least one compound selected from the group consisting ofanestetics, analgesics and anti-furtility agents.

28. An article as set forth in claim 20, wherein said body memberincludes a container portion. integral therewith and formed of latex,said container portion opening to the surface of said body member andterminating in an enlarged globular member of silicone elastomericmaterial capable of releasing therefrom uniformly and gradually over aprolonged period of time a medicament contained therein. said containerportion being capable of being refilled by the introduction ofmedicament therethrough from a hypodermic syringe.

29. An article as set forth in claim 28 wherein said body member is ofsuch length that it can extend through the cervix while the convolutemember is seated in the uterus.

30. An article as set forth in claim 29, wherein said container memberis filled with a medically acceptable solution of an antibiotic orantibacterial agent for the prevention, treatment or cure of thesyphilis or gonorrhea organisms.

1. An intrauterine contraceptive device comprising: a. a thin, elongatedbody member having a longitudinal axis, a proximal end and a distal end;b. a pair of arms extending substantially transversely with respect tosaid axis, each arm having an outer end; c. each of said outer endsterminating in a convolute member which extends downwardly toward theproximal end of said body member and inwardly toward said body memberand having a connecting section connecting each convolute member to saidbody member; d. each of said convolute members including at least threesubstanially elongated leg segments substantially parallel to said bodymember and connected to substantially arcuate segments; and e. saidbody, arms and convolute members being formed of a flexiblethermoplastic material.
 2. An article as set forth in claim 1, whereinsaid body member includes a container portion, integral therewith andformed of latex, said container portion opening to the surface of saidbody member and terminating in an enlarged globular member of siliconeelastomeric material capable of releasing therefrom uniformly andgradually over a prolonged period of time a meDicament containedtherein, said container portion being capable of being refilled by theintroduction of medicament therethrough from a hypodermic syringe.
 3. Anarticle as set forth in claim 2 wherein said body member is of suchlength that it can extend through the cervix while the convolute memberis seated in the uterus.
 4. An article as set forth in claim 2, whereinsaid container is filled with a medically acceptable solution of anantiobiotic or antibacterial agent for the prevention, treatment or cureof the syphilis or gonorrhea organisms.
 5. An article as set forth inclaim 1, wherein the proximal end of said body member terminates in apair of downwardly extending divergent, flexible legs.
 6. An article asset forth in claim 5, wherein each of said legs is at an angle ofapproximately 5* with respect to the axis of said body member.
 7. Anarticle as set forth in claim 5, including at least two strands of thin,flexible material, each having a distal end, and means fastening thedistal end of a strand to the proximal end of each of said legs.
 8. Anarticle as set forth in claim 1, wherein said body member includes, asan integral part thereof, an elongated member of a magnetic materialoccupying at least one-half of its length and at least 80% of itscross-section.
 9. An article as set forth in claim 8, wherein saidmagnet is located proximate the distal end of said body member.
 10. Anarticle as set forth in claim 1, wherein said arms extend in a directionwhich is substantially transverse to the axis of said body member, andsaid convolute members having outer legs which are dependent from saidarms, said convoluted members being generally sinusoidal inconfiguration.
 11. An article as set forth in claim 1, wherein at leastthe surface of said arms, said convolute members, and a substantialportion of said body member are covered with a silicone elastomericmaterial.
 12. An article as set forth in claim 1, wherein said articleis formed of a medically acceptable material having plastic memory,whereby said arms aand convolute members may be deformed to besubstantially coextensive with the axis of said body and will, aftersuch deformation, return to their original configurations.
 13. Anarticle as set forth in claim 1, wherein each of said body member andconvolute members are of rounded edge non-circular cross-section.
 14. Anarticle as set forth in claim 1, including a thin copper wire coveringat least a portion of each of said convolute members, each of saidcopper wires having a surface area of at least 100 millimeters.
 15. Anarticle as set forth in claim 1, wherein said thermoplastic materialincludes a radio-opaque material incorporated therein.
 16. An article asset forth in claim 1, including at least one thin, flexible strand ofmaterial having a distal end, and means fastening said distal end to theproximal end of said body member.
 17. An article as set forth in claim1, wherein at least a portion of the surface of said article is formedof medically acceptable silicone elastomeric material havingincorporated therein for controlled release in utero at least onecompound selected from the group consisting of anesthetics, analgesicsand anti-furtility agents.
 18. Apparatus as set forth in claim 1,wherein said body member has maximum outside diameter of about 4 mm. 19.An intrauterine contraceptive device comprising: a. a thin, elongatedbody member having a longitudinal axis, a proximal end and a distal end;b. a pair of divergent arms connected to the distal end of said body,each of said arms terminating in a convolute member which extendsdownwardly toward the proximal end of said body and inwardly toward saidbody member; c. each of said convolute members ending in a free endproximate said body member, one of said free ends being closer to saidbody member than the other and comprising a bulbous member; d. each ofsaid convoluted members including at least three substantially elongatedleg segments substantially parallel to said body member andinterconnected by arcuate segments; and e. said body, arms and convolutemembers being formed of a flexible thermoplastic material
 20. Anintrauterine contraceptive device compaising: a. a thin, elongated bodymember having a longitudinal axis, a proximal end and a distal end; b. apair of short connecting arms connected to the distal end of said bodymember, each of said arms terminating in a convolute member whichextends downwardly toward the proximal end of said body and outwardlyfrom said body member; c. each of said convolute members ending in afree arm remote from said body member and extending inwardly toward saidbody member proximate the distal end thereof; d. each of said convolutedmembers including at least three substantially elongated, substantiallylinear leg segments substantially parallel to said body member andinterconnected by arcuate segments; and e. said body, arms and convolutemembers being formed of flexible thermoplastic material.
 21. An articleas set forth in claim 20, wherein the proximal end of said body memberterminates in a pair of downwardly extending divergent, flexible legs.22. An article as set forth in claim 21, wherein each of said legs is atan angle of approximately 5* with respect to the axis of said bodymember.
 23. An article as set forth in claim 20, wherein said armsextend in a direction which is substantially transverse to the axis ofsaid body member, and said convolute members have outer legs which aredependent from said arms, said convoluted members being generallysinusoidal in configuration.
 24. An article as set forth in claim 20,wherein at least the surfaces of said arms, said convolute members, anda substantial portion of said body member are covered with a siliconeelastomeric material.
 25. An article as set forth in claim 20, whereinsaid article is formed of a medically acceptable material having plasticmemory, whereby said arms and convolute members may be deformed to besubstantially coextensive with the axis of said body and will, aftersuch deformation, return to their original configurations.
 26. Anarticle a set forth in claim 20, wherein each of said body member andconvolute members are of rounded edge non-circular cross-section.
 27. Anarticle as set forth in claim 20, wherein at least a portion of thesurface of said article is formed of medically acceptable siliconeelastomeric material having incorporated therein for controlled releasein utero at least one compound selected from the group consisting ofanestetics, analgesics and anti-furtility agents.
 28. An article as setforth in claim 20, wherein said body member includes a containerportion, integral therewith and formed of latex, said container portionopening to the surface of said body member and terminating in anenlarged globular member of silicone elastomeric material capable ofreleasing therefrom uniformly and gradually over a prolonged period oftime a medicament contained therein, said container portion beingcapable of being refilled by the introduction of medicament therethroughfrom a hypodermic syringe.
 29. An article as set forth in claim 28wherein said body member is of such length that it can extend throughthe cervix while the convolute member is seated in the uterus.
 30. Anarticle as set forth in claim 29, wherein said container member isfilled with a medically acceptable solution of an antibiotic orantibacterial agent for the prevention, treatment or cure of thesyphilis or gonorrhea organisms.